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Abstract:

Disclosed is a safety needle assembly has a needle guard that prevents
accidental needle sticks before and after an injection. A locking collar
rotates during use as an inner protrusion follows three paths of a track
located on the outer surface of a body housing. When the inner facing
protrusion is in the third path, it encounters a hard stop and a
rotational bias that locks the guard from further retraction and, thus,
covers the sharp distal end of the needle.

Claims:

1-16. (canceled)

17. A needle assembly attachable to a drug delivery device, comprising a.
a housing having an outer surface, a proximal end, and a distal end, at
least one track being provided on the outer surface of the housing, b. at
least one needle cannula, c. a locking collar having a bearing surface
and an inner surface, where the inner surface comprises at least one
protrusion which is configured to mechanically cooperate with the at
least one track, d. a needle guard adapted and arranged to provide
protection of the at least one needle cannula, the needle guard being
configured to engage the locking collar through the bearing surface.

18. The needle assembly of claim 17, wherein each protrusion is
configured to mechanically cooperate with one respective track.

19. The needle assembly of claim 17, wherein the needle cannula comprises
a measurable diameter and the needle cannula is configured to be mounted
in the housing, and wherein the needle guard comprises a needle pass
through hole having a diameter D that is no more than ten times greater
than the diameter of the needle cannula.

20. The needle assembly according claim 17, comprising a biasing member
which is adapted and arranged to exert an axial biasing force onto the
needle guard and the locking collar, the biasing member being configured
to be engaged with the housing, wherein one end of the biasing member is
engaged with a lip on the inner surface of the locking collar.

21. The needle assembly according to claim 17, wherein the track
comprises a first, a second and a third path.

22. The needle assembly of claim 21, wherein the needle guard is axially
moveable with respect to the housing between an extended and a retracted
position, and wherein the protrusion is configured to mechanically
cooperate with the first and second path during retraction and partial
extension of the needle guard.

23. The needle assembly of claim 21, wherein the protrusion is configured
to mechanically cooperate with the third path during final extension of
the needle guard into a locking position where the needle guard is
configured to be prevented from further axial movement with respect to
the housing.

24. The needle assembly according to any of claim 20, comprising an outer
sleeve which is configured to be fixed to the housing, the outer sleeve
being configured to surround the collar and the biasing member, wherein
the outer sleeve comprises at least one opening for viewing indicia
provided on an outer surface of the locking collar, wherein the indicia
are configured to indicate a pre-use ready position of the needle guard
before an injection is performed and a locked position of the needle
guard.

25. The needle assembly according to claim 17, wherein the bearing
surface comprises a crown arranged on the inner surface of the locking
collar, the crown being configured to mechanically cooperate with a
plurality of angled surfaces arranged on the proximal end of the needle
guard to rotationally bias the collar.

26. The assembly according to claim 21, wherein the locking collar is
configured to rotate under at least one of the following conditions: the
protrusion moves from the first path to the second path; a biasing torque
is created by mechanical interaction between the needle guard and the
locking collar due to the biasing force exerted on the locking collar and
the needle guard by the biasing member; a biasing torque is created by
the biasing member or an additional biasing member.

27. The needle assembly according to claim 24, wherein the needle guard
is rotationally constrained by the outer sleeve and the locking collar is
rotationally constrained when the protrusion mechanically cooperates with
the first path of the track, and wherein the assembly provides an audible
and/or tactile indication to a user when the locking collar rotates as
the protrusion moves from the first path to the second path.

28. The needle assembly according to any of claim 25, wherein, when the
protrusion mechanically cooperates with the third path, the crown and the
angled surfaces on the needle guard are configured to mechanically
cooperate with each other, the collar and the needle guard being in a
biasing relationship provided by the biasing member such that the needle
guard is prevented from further axial movement, the needle assembly thus
being in a post-use lock out state.

29. The needle assembly according to claim 17, wherein the housing
comprises an upper body and a lower body, where the lower body is
connected to the upper body.

30. The needle assembly of claim 29, wherein the biasing member is
adapted and arranged to be engaged with one of the upper body and the
lower body and the outer sleeve is configured to be fixed to the lower
body.

31. The needle assembly of claim 29, wherein the at least one track is
provided by at least one of the upper body and the lower body.

32. The needle assembly according to claim 29, wherein the assembly
comprises an inner cavity provided by the upper body and the lower body.

Description:

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application is a U.S. National Phase Application
pursuant to 35 U.S.C. §371 of International Application No.
PCT/EP2011/054419 filed Mar. 23, 2011, which claims priority to U.S.
Provisional Patent Application No. 61/317,548 filed on Mar. 25, 2010 and
European Patent Application No. 10170281.9 filed Jul. 21, 2010. The
entire disclosure contents of these applications are herewith
incorporated by reference into the present application.

FIELD OF THE INVENTION

[0002] Specific embodiments of this disclosure relate to an improved
needle assembly, specifically a pen needle and safety shield system, but
not exclusively, adapted for pen injectors. Specifically, our disclosure
concerns a needle assembly that prevents accidental needle sticks before
and after use. The safety shield system of this disclosure includes a
retractable generally tubular guard or shield that is spring biased to
normally enclose the cannula mounted in the assembly, but which locks in
the extended position enclosing the cannula following injection.

BACKGROUND

[0003] Needle assemblies are commonly used to either inject substances
into or extract substances out of human or animal bodies. Such needle
assemblies are typically disposable and are discarded after only one use.
The problem presented by the disposal of a needle assembly, and indeed,
by any handling of the needle assembly, is the potential risk of being
injured by the sharp end of the cannula. This is particular dangerous for
health care professionals (HCPs) or similar care givers following the
penetration of the skin because the needle cannula may become
contaminated with body fluids and therefore capable of spreading diseases
such as hepatitis and HIV. A number of safety needle assemblies have been
developed where a telescopically movable shield conceals the needle
cannula during the injection.

[0004] Hypodermic syringes have been used for many years to deliver
selected doses of fluids including liquid medicaments, inoculations, etc.
to patients. However, many applications using hypodermic needles are
self-administered, including, for example, insulin, antihistamines, et
cetera. The required manipulation of a standard prior art hypodermic
syringe can be inconvenient, particularly where the injection is
self-administered in a public environment. Medication delivery pens or
pen injectors have therefore been developed to facilitate
self-administration of injections. A typical pen injector includes a
generally tubular body portion resembling a fountain pen that receives a
vial of fluid, such as insulin, antihistamines, et cetera, having a
pierceable closure, such as a rubber septum. The pen needle may include a
hub generally having a double-ended cannula including a first end that
extends into the body portion of the pen injector for piercing the
closure of the vial and a second end used for injection of the fluid
contained in the vial. The pen needle also may include a removable
cup-shaped cap that encloses the second end of the needle cannula prior
to use.

[0005] Various improvements in pen needles have been developed or proposed
by the prior art since their introduction. Various safety shield systems
have also been developed or proposed by the prior art for conventional
hypodermic syringes, wherein a tubular shield is spring biased to enclose
the needle cannula following injection and including safety shields which
lock in the extended enclosed position following injection. Such safety
shield systems for conventional hypodermic syringes are operated
manually, thus requiring additional action (active systems), such as
force, to activate as compared to the standard injection process. Hand
manipulated safety shield systems may include spiral or complicated
channel-shaped tracks on an inside surface of the shield which guide the
shield during extension of the shield to enclose the needle cannula and
to lock the shield in the extended position. However, such complicated
systems may not always be reliable. There are also safety pen needle
systems known that are automatic in nature, whereby, when the shield is
retracted to its initial position, the needle is locked from further use.
It would be desirable to simplify the operation of such known devices to
eliminate manual manipulation or rotational movement of the shield from
the retracted position to a locked extended position and to improve upon
the smoothness of operation. Likewise, it would be beneficial to provide
the user with audible and/or tactile feedback during use and to have a
reliable locking mechanism.

[0006] The needle assembly of the present disclosure solves these problems
by providing a safety shield which normally encloses the needle cannula
prior to use, permits refraction of the safety shield during injection,
provides audible and/or tactile feedback during the insertion stroke and
provides a secure locking feature that locks the shield in the extended
enclosed position following use. By incorporating the locking element as
part of a rotating collar, it can additionally easily serve the purpose
of indicating device status through visual indicia.

[0007] Moreover, our disclosure comprises one or more inwardly facing
protrusions on a locking collar that allow the needle assembly to have
the biasing member located on the outside of the main housing. This
further provides the use of tracks and blocking surfaces located on the
outside of the housing instead on the inner surface of the housing, thus
allowing the biasing member to have a much wider inner diameter. This
also has the advantage of providing additional space in the center of the
needle shield, e.g. a cavity, that can be used for several features,
preferably for introducing a drug container. Since there is no limiting
factor for the biasing member diameter, this provides more design
variation in setting up the retraction force of the needle guard to aid
in the user's convenience.

[0008] These and other advantages and features will become evident from
the following more detailed description of the invention.

[0009] One problem to be solved by the present invention is to provide a
needle assembly and a drug delivery device where the safety and comfort
of the user is increased.

SUMMARY

[0010] The disclosed needle assembly may contain a needle guard that can
reduce the risk of accidental needle sticks before and after use as well
as reduce the anxiety of users suffering from needle phobia. The guard is
preferably configured with a solid planar surface at its distal end that
provides a large surface area that may reduce the pressure exerted on the
patient's skin, which allows the user to experience an apparent reduction
in the force exerted against the skin. Preferably, the planar surface
covers the entire distal end of the guard with the exception of a small
needle pass through hole aligned axially with the needle. This pass
through hole is preferably no more than 10 times greater in diameter than
the outer diameter of the needle cannula. For example, with a needle
outside diameter of 0.34 mm, the pass through hole diameter D can be 3.4
mm. Preferably, the pass through hole size should be large enough for the
user to see that the device is primed, e.g. the user may be able to see a
drop or more of medicament. This difference between the hole size and
cannula diameter is to allow for tolerances and also to allow users to
see the drop of liquid on the end of the cannula after priming. Further,
the movable guard or shield is configured to move axially in both the
distal and proximal directions when pressed against an injection site.
When the needle assembly is removed or withdrawn from the patient, the
guard may be returned to its original starting location and may be
securely locked with respect to the housing. This may be achieved by a
rotating locking collar, that may securely lock into the housing through
one or more inwardly projecting protrusions or pips such that the guard
will be locked from further substantial axial, in particular proximal,
movement. By "substantial" movement we do not mean the typically amount
of "play" in system, but instead we mean that the guard does not move
axially a distance that exposes the distal end of the cannula.

[0011] According to one aspect, a needle assembly is provided. The needle
assembly may be, preferably releasably, attachable to a drug delivery
device. The needle assembly may comprise a housing. The housing may have
an outer surface. The housing may have a proximal end and a distal end.
At least one track, preferably two or more tracks, may be provided on the
housing. The at least one track may be provided on the outer surface of
the housing. The housing, preferably the proximal end of the housing, may
have a connector. The connector may be configured for, preferably
releasable attachment to the drug delivery device. The needle assembly
may comprise at least one needle cannula. The needle assembly may
comprise a locking collar. The locking collar may have a bearing surface.
The locking collar may have an inner surface. The locking collar, in
particular the inner surface of the locking collar, may comprise at least
one, preferably inwardly facing, protrusion. In particular, the number of
protrusions may correspond to the number of tracks provided on the
housing. The at least one protrusion may be configured to mechanically
cooperate with the at least one track. In particular, each protrusion may
be configured to mechanically cooperate with one respective track. The
needle assembly may comprise a needle guard. The needle guard may be
adapted and arranged to provide protection of the at least one needle
cannula. The needle guard may be configured to mechanically cooperate
with, in particular to engage, the locking collar through the bearing
surface.

[0012] According to one embodiment, the needle cannula comprises a
measurable diameter. The needle cannula may be configured to be mounted
in the housing. The needle guard may comprise a hole where a needle can
pass through. The needle pass through hole may have a diameter D that is
no more than ten times greater than the diameter of the needle cannula.

[0013] The needle assembly may be attachable to the drug delivery device,
preferably a pen shaped injection device, comprising, the housing having
the outer surface, the proximal end, and the distal end. The proximal end
of the housing may have the connector configured for, preferably
releasable, attachment of the needle assembly to the drug delivery
device. This connector can be any connector design, such as threads, snap
fits, bayonet, lure lock, or combination of these designs. The needle
cannula, preferably a doubled ended needle for use with a pen type
injector, is mounted in the housing having a measurable diameter. The
needle cannula may be mounted inside the housing using any technique
known to those skilled in the art, such as welding, gluing, friction fit,
and the like.

[0014] According to one embodiment, the needle assembly comprises a
biasing member. The biasing member may be adapted and arranged to exert
a, preferably axial, biasing force onto the needle guard and the locking
collar. The, preferably permanent, axial biasing force may be directed in
the distal direction with respect to the housing. The biasing member may
be configured to be engaged with the housing. One end of the biasing
member may be engaged with a lip on the inner surface of the locking
collar.

[0015] The assembly contains the biasing member engaged with the housing,
preferably a lip or ridge located on the outer surface. A preferred
biasing member is a spring, however, any type of member that produces a
biasing force on the needle guard will work.

[0016] The assembly comprises one or more tracks. The at least one track
may comprise a first path. The at least one track may also comprise a
second path. Furthermore, the at least one track may comprise a third
path. The assembly comprises one or more protruding features, e.g.
protrusions, pips or the like. The number of protruding features may
correspond to the number of tracks. Each protruding feature may be
configured and arranged to mechanically cooperate with one respective
track. In particular, one respective protruding feature may be configured
and arranged to be guided by one respective track.

[0017] According to one embodiment, the needle assembly comprises one
track, and one protrusion. The track may comprise a first path. The track
may also comprise a second path. Furthermore, the track may comprise a
third path. The first, second and third path may be connected with one
another, e. g. in a way as to result in one continuous track with
different sections formed by the individual paths.

[0018] According to one embodiment, the needle guard is axially moveable
with respect to the housing between an extended, e.g. a distal, and a
retracted, e.g. a proximal position. The protrusion may be configured to
mechanically cooperate with the first and second path during retraction
and partial extension of the needle guard. The protrusion may be
configured to mechanically cooperate with the third path during final
extension, e.g. extension after the injection, of the needle guard into a
locking position. In the locking position, the needle guard may be
configured to be prevented from further axial, in particular proximal,
movement with respect to the housing.

[0019] According to an embodiment, the needle assembly comprises an outer
sleeve. The outer sleeve may be configured to be, permanently or
releasably, fixed to the housing. The outer sleeve may be configured to
surround the collar and the biasing member. The outer sleeve may have at
least one opening or window. The outer sleeve may comprise two, three or
more openings or windows. Preferably, the outer sleeve comprises three
openings or windows such that the user may be able to view the opening or
window irrespective of the position of the device and, hence, the needle
assembly, with respect to the user. The opening or window may be adapted
and arranged for viewing indicia, e.g. symbols or numbers, provided on an
outer surface of the locking collar. The indicia may be configured to
indicate a pre-use ready position of the needle guard before an injection
is performed. The indicia may be configured to indicate a locked position
of the needle guard.

[0020] The assembly has the outer sleeve that may be axially and
rotationally fixed to the housing and that may surround the locking
collar and biasing member. The outer sleeve may have the opening or
window that allows the user to view markings, color or other indicia on
the outer surface of the locking collar before and/or after use.
Preferably, user noticeable indicia indicate both the pre-use position
(i.e. ready to use or unused) and the post-use locked position (i.e.
used) of the guard after the assembly has been used to perform an
injection.

[0021] According to an embodiment, the bearing surface comprises a crown.
The crown may be arranged on the inner surface of the locking collar. The
crown may be configured to mechanically cooperate, in particular to
engage, with a plurality of angled surfaces. The angled surfaces may be
arranged on the proximal end of the needle guard. The crown may be
configured to mechanically cooperate with the plurality of angled
surfaces to rotationally bias the collar.

[0022] According to an embodiment, the locking collar is configured to
rotate when the protrusion moves from the first path to the second path.
Additionally or alternatively, the locking collar may be configured to
rotate under a biasing torque created by mechanical interaction between
the needle guard and the locking collar due to the, preferably permanent,
axial biasing force exerted on the locking collar and the needle guard by
the biasing member. Additionally or alternatively, the locking collar may
be configured to rotate under a biasing torque created by the biasing
member or an additional biasing member.

[0023] To prevent reuse of the needle assembly, the disclosure includes
the previously mentioned locking collar. The locking collar may have the
inner surface that surrounds a portion of the housing and is free to
rotate within the defined track area on the outside surface of the
housing. The inner surface of the collar can have the bearing surface,
such as the crown. Furthermore, the inner surface of the collar can have
the inner facing protrusion or pip that is slidably engaged with the
track on the outer surface of the housing. Preferably, the crown
comprises a number of distal facing angled surfaces (so-called "dog
teeth") that act as bearing surfaces. These teeth interact with the
similarly angled faces on the needle guard and cause the collar to
experience a torque that is initially resisted by the interaction of the
protrusion within the track when the needle assembly is used. The needle
guard has a distal end and a proximal end, where the proximal end
comprises the plurality of angled surfaces (i.e. another corresponding
set of dog teeth) that are suitable to engage and bias the crown on the
locking collar both rotationally and axially. One end of the biasing
member is engaged with the lip on the inside surface of the locking
collar and the other end is engaged with the housing near the proximal
end.

[0024] According to one embodiment, the needle guard is always
rotationally constrained by the outer sleeve. The locking collar may be
rotationally constrained when the protrusion mechanically cooperates with
the first path of the track. The assembly may provide an audible and/or
tactile indication to a user when the locking collar rotates as the
protrusion moves from the first path to the second path.

[0025] Preferably, the one or more tracks located on the outside surface
of the housing has one or more sets of first, second and third paths. The
one or more protrusions on the inner surface of the locking collar may
travel in the first and second paths during retraction and partial
extension of the guard. The protrusion may move to the third path and
into a locking position, e.g. an axial position where it is prevented
from further axial and rotational movement, when the guard is fully
extended. The guard may be, preferably permanently, rotationally
constrained by the outer sleeve, preferably by the use of one or more
spline features in the outer surface of the guard in cooperation with one
or more followers or pips located at the distal end of the outer sleeve.
The locking collar may be rotationally constrained when the protrusion is
in the first path of the track. As the protrusion is moved axially in the
proximal direction when the guard pushes the locking collar during
retraction, the protrusion moves from the first track to the second track
causing the assembly to emit an audile sound and/or tactile feedback.
This tells the user that the device may now have been activated to lock
upon extension of the guard in the distal direction.

[0026] According to one embodiment, when the protrusion mechanically
cooperates with the third path, the crown and the angled surfaces on the
needle guard are configured to mechanically cooperate with each other.
The collar and the needle guard may be in preferably permanent, biasing
relationship provided by the biasing member such that the needle guard is
prevented from further axial, in particular proximal, movement, the
needle assembly thus being in a post-use lock out state.

[0027] According to one embodiment, the housing comprises an upper body.
The housing may comprise a lower body. The lower body may be, releasably
or permanently, connected to the upper body.

[0028] According to one embodiment, the biasing member is adapted and
arranged to be, permanently or releasably, engaged with the lower body.
Additionally or alternatively, the biasing member may be adapted and
arranged to be, permanently or releasably, engaged with the upper body.
The outer sleeve may be configured to be, permanently or releasably,
fixed to the lower body.

[0029] According to one embodiment, the at least one track or at least a
portion of the at least one track may be provided by the upper body, in
particular an outer surface of the upper body. Additionally or
alternatively, the at least one track or at least a portion of the at
least one track may be provided by the lower body, in particular an outer
surface of the lower body

[0030] The arrangement of the upper body and the lower body may provide on
its outer surface at least one, preferably two or more tracks.

[0031] The bearing surface on the locking collar may engage the proximal
end of the guard. The inner surface of the locking collar may comprise
the lip to engage the biasing member. The inner surface may have the
inner facing protrusion that is slidably engaged with the track that is
on the outer surfaces of the lower and upper bodies.

[0032] According to one embodiment, the assembly comprises an inner
cavity. The inner cavity may be provided by the upper body and/or the
lower body.

[0033] In yet another embodiment, there is provided a needle assembly
attachable to a drug delivery device, comprising an upper body having an
outer surface, a proximal end, and a distal end, where the proximal end
may have a connector configured for attachment to the drug delivery
device. A lower body having an outer surface is connected to the upper
body such that it is in the same plane as a portion of the upper body
outer surface. The outer surfaces of both the upper body and the lower
body together may form the track The proximal end of the lower body may
have the connector for attachment to the drug delivery device or,
alternatively, both the upper and lower bodies could share the connector.
A needle cannula is mounted on the inside of the upper body. A spring or
other biasing member is engaged with a portion of the outer surface of
the lower body. The biasing member is also engaged with a locking collar,
preferably through a lip located on the inner surface, where the inner
surface also has a protrusion that is slidably engaged with a track that
is formed on the outer surfaces of both the lower and upper bodies.

[0034] A needle guard or shield may be also part of this alternative
embodiment, which has a distal end and a proximal end, where the proximal
end engages a bearing surface on the distal end of the locking collar. An
outer sleeve may be rotationally and axially fixed to the lower body and
may be configured to surround the locking collar and biasing member, and
to retain the guard in the assembly against the biasing force.

[0035] According to a preferred embodiment, a needle assembly is provided
which is attachable to a drug delivery device. The needle assembly
comprises a housing having an outer surface, a proximal end, and a distal
end. At least one track is provided on the outer surface of the housing.
The needle assembly comprises at least one needle cannula. The needle
assembly comprises a locking collar having a bearing surface and an inner
surface, where the inner surface comprises at least one protrusion. Each
protrusion is configured to mechanically cooperate with one respective
track. The needle assembly comprises a needle guard adapted and arranged
to provide protection of the at least one needle cannula, the needle
guard being configured to engage the locking collar through the bearing
surface.

[0036] According to another embodiment, a needle assembly is provided
which is attachable to a drug delivery device. The needle assembly
comprises a housing having an outer surface, a proximal end, and a distal
end. The needle assembly comprises a needle cannula having a measurable
diameter mounted in the housing. The needle assembly comprises a biasing
member engaged with the housing. The needle assembly comprises a locking
collar having a bearing surface and an inner surface, where the inner
surface has an inwardly facing protrusion that is slidably engaged with a
track on the outer surface of the housing. The needle assembly comprises
a guard having a distal end and a proximal end, where the proximal end
engages the locking collar through the bearing surface. The needle
assembly comprises an outer sleeve fixed to the housing that surrounds
the locking collar and biasing member.

[0037] These as well as other embodiments of various aspects of the
present invention will become apparent to those of ordinary skill in the
art by reading the following detailed description, with appropriate
reference to the accompanying figures.

[0038] The scope of the invention is defined by the content of the claims.
The invention is not limited to specific embodiments but comprises any
combination of elements of different embodiments. Moreover, the invention
comprises any combination of claims and any combination of features
disclosed by the claims.

BRIEF DESCRIPTION OF THE FIGURES

[0039] Exemplary embodiments are described herein with reference to the
figures, in which:

[0049] FIG. 10 illustrates a cross-sectional view of the embodiment of
FIG. 9;

[0050] FIG. 11 illustrates the lower body of the embodiment of FIG. 9;

[0051] FIG. 12 illustrates the upper body of the embodiment of FIG. 9;

[0052] FIG. 13 illustrates the lower and upper bodies as assembled for the
embodiment of FIG. 9;

[0053]FIG. 14 illustrates a perspective view of the locking collar of the
embodiment of FIG. 9;

[0054] FIG. 15 illustrates a perspective view of the guard of the
embodiment of FIG. 9;

[0055]FIG. 16 illustrates a perspective view of the outer sleeve of the
embodiment of FIG. 9;

[0056] FIG. 17 illustrates the paths of the tracks and the starting
position of the protrusions of the embodiment of FIG. 9; and

[0057] FIG. 18 illustrates the paths of the tracks and the ending position
of the protrusions of the embodiment of FIG. 9.

DETAILED DESCRIPTION

[0058]FIG. 1 shows an exploded view of one possible embodiment of the
needle assembly 1 comprising six parts: a housing 2, a needle cannula 3
mounted inside the housing 2, a biasing member 4, shown as a compression
spring, a rotatable locking collar 5, a needle guard 6, and an outer
sleeve 7. FIG. 2 shows these parts assembled in a cross-sectional view,
where the outer sleeve 7 is rotationally and axially fixed to the housing
2 and acts to hold the parts of the assembly together. A connector 8,
shown as threads, is located at the proximal end of housing 2. The
connector 8 is configured for attachment to a drug delivery device. The
compression spring 4 and locking collar 5 are assembled onto the housing
2 prior to connecting the outer sleeve 7 forming one sub-assembly. The
needle guard 6 is slidably assembled to the inside of the outer sleeve 7
to form a second sub-assembly. Once assembled, the housing 2 and outer
sleeve 7 are securely fixed such that they form a single unit. The two
sub-assemblies can be connected together in any manner known to the art,
preferably using a snap fit, however these sub-assemblies can be welded,
glued, friction pressed, or pinned together. Regardless of the manner of
attachment, the compression spring 4, locking collar 5, and needle guard
6 may all be able to move within these body components.

[0059] The compression spring 4 acts between the housing 2 and the locking
collar 5 to axially bias the needle guard 6 into an extended (guarded)
position as illustrated in FIG. 2. The distal end of the spring 4 engages
an inner lip 30 arranged on the inner surface 13 of collar 5. The
proximal end of the spring 4 engages a groove 27 of the housing 2.

[0060] The locking collar 5 has a crown 10 that comprises one or more
inwardly protruding features, protrusions, pips, or like structures 11.
Said protruding features 11 run in one or more tracks 12 or guide ways
formed in the outer surface 35 of the housing 2. As shown in FIG. 3,
track 12 has three paths, 14, 15, and 16, that have a specific geometry
such that after a single use of the needle assembly 1, the inwardly
protruding feature 11 is blocked from further axial movement and the
guard 6 (and, thus, the device) is "locked" in a guarded, e.g. distal,
position, where the distal end of the needle 3 is completely and safely
covered by the guard 6. The crown 10 comprises one or more angled distal
facing bearing surfaces to engage like surfaces facing proximally on
guard 6.

[0061] The needle guard 6 is, preferably permanently, rotationally
constrained by the outer sleeve 7 through a splined engagement of one or
more protrusions 20 of the outer sleeve 7 in one or more slots 18 of the
guard 6 (see FIGS. 5 & 6). Although spring 4, preferably permanently,
biases guard 6 in the distal direction, the guard 6 is retained in the
outer sleeve 7 by interaction between retention ridge 26 on the distal
end of outer sleeve 7 and proximal lip 25 of the guard 6. A crown 17 at
the proximal end of the needle guard 6 interacts through proximally
facing bearing surfaces 32 or "dog teeth" with the similarly shaped crown
10 formed on the inside of the locking collar 5.

[0062] One unique feature of the needle assembly 1 is the user feedback
that is given when the assembly 1 is used. In particular, the assembly 1
emits an audible and/or tactile "click" to indicate to the user that the
needle guard 6 will lock safely out upon completion of the injection.
This audible and/or tactile feature works as follows. As mentioned, the
needle guard 6 is, preferably permanently, rotationally constrained by
the outer sleeve 7. The set of dog teeth 32 on the crown 17 at the
proximal end of the needle guard 6 interacts with a similar set of dog
teeth 31 formed on the inside of the locking collar 5. In the initial
position, the two sets of teeth 31, 32 are unable to completely mesh,
i.e. they are in an axially biased engagement. In particular, the dog
teeth 31, 32 are kept in distance and pushed or pressed together due to
the biasing force exerted by the spring 4, as best shown by FIG. 7.
Likewise, guard 6 is rotationally constrained by outer sleeve 7 and the
collar 5 is rotationally constrained by its inwardly facing protrusion 11
interacting with path 14 of track 12. In particular, the spring 4 applies
force in the distal direction on the proximal end of locking collar 5
such that the collar 5 is urged to move axially and is rotationally
biased along the angled bearing surfaces 31 and 32. Due to the angled
surfaces of dog teeth 31, 31, the axially directed force may tend to
induce a rotation of the locking collar 5. However, this rotation may be
prevented due to mechanical cooperation of the protrusion 11 and path 14
of track 12. In particular, the dog teeth 31 and 32 are prevented from
meshing because face 83 of protrusion 11 is biased against wall 80. As
the guard 6 pushes the locking collar 5 in the proximal direction,
protrusion 11 will move proximal along path 14 until the lower most edge
82 moves past point 84 on path 14. Once edge 82 clears point 84 following
along track 12 as indicated by arrow 39, the locking collar 5, along with
protrusion 11, is free to rotate as the dog teeth 31, 32 try to mesh.
This causes face 83 of protrusion 11 to collide with wall 81 of path 15,
which provides an audible sound, as well as a tactile feel, to the user
indicating that the device is now ready for injection. The rotational
torque generated by the interaction of the dog teeth 31 and 32, in
particular the angled surfaces of the dog teeth 32, 32, converts axial
movement of the needle guard 6 into rotation of the locking collar 5 such
that protrusion 11 is brought into mechanical cooperation with path 15.
Accordingly, no rotational bias of the locking collar 5 is required, e.g.
by means of spring 4. Alternatively, the rotational torque needed to
cause the rotation of the locking collar 5 may be provided by spring 4
providing the previously mentioned axial bias and, additionally, a
rotational bias. Alternatively, the rotational torque needed to cause the
rotation of the locking collar 5 may be provided by an additional spring
(not explicitly shown) or clamping arms (not explicitly shown).

[0063] When the needle assembly 1 is used, the needle guard 6 is pushed in
the proximal direction as the planar surface 33 comes into contact with
an injection site or other stationary surface. This proximal movement of
the guard 6 pushes the collar 5 also in the proximal direction as
described above. After a predetermined distance, which is set by the
intersection of paths 14 and 15, the locking collar 5 is forced to rotate
under the rotational torque generated by the interaction of the dog teeth
31 and 32 due to the axially directed biasing force exerted on the collar
5 by the spring 4. As described above, the collar 5 "snaps" around (i.e.
slightly rotates) as the two sets of dog teeth 31, 32 seek to become
meshed. This sudden rotational movement of the collar 5 and the abrupt
collision of face 83 of the inwardly facing protrusion 11 with the side
wall 81 of the path 15 provides the user with the audible and/or tactile
"click". Said "click" may indicate that the point of no return has been
reached, i.e. when the spring 4 returns the needle guard 6 to an extended
position, the, the needle guard 6 will be locked irrespective of whether
an injection has been performed after the "click" or not.

[0064] As mentioned, the distal end of the guard 6 has the planar surface
33 that provides an added measure of safety and reduces the pressure
exerted by the guard 6 on the injection site during an injection with the
needle assembly 1. Because the planar surface 33 substantially covers
access to the needle 3, a user is prevented from gaining access to the
distal tip of the needle 3 after the assembly 1 is in the locked
position. Preferably, the diameter D of needle pass through hole 9 in the
planar surface 33 is no more than 10 times that of the outer diameter of
needle cannula 3.

[0065] The housing 2 also has alignment feature 34 that interacts or
engages with a corresponding alignment feature (not shown) on the outer
sleeve 7. Such an alignment feature 34 ensures correct positioning of the
one or more windows 19 relative to locking collar 5. The collar 5
preferably has at least one indicia shown as a colored area 21 in FIG. 4.
The at least one indicia is visible through the at least one opening in
the outer sleeve 19. The indicia provide the user with a visual notice
that the guard 6 is in a locked position. For example, a green color on
the locking collar 5 in position 22 could indicate the needle assembly 1
is ready for use and a band of red color in position 21 could be used to
indicate that the assembly 1 has been used and is locked. Alternatively,
graphics, symbols or text could be used in place of color to provide this
visual information / feedback.

[0066] FIGS. 7 and 8 illustrate two-dimensionally the movement (see
directional arrow 39) of the inwardly facing protrusion 11 from the
initial position (FIG. 7) to the final locked position (FIG. 8) as the
protrusions 11 on the locking collar 5 follow the paths 14, 15, and 16 in
track 12 on the outer surface 35 of the housing 2. It is within the scope
of our invention that a number of tooth arrangements and/or profiles
could be used to fulfill the required function such as providing the
torque and/or the "click" described above, e.g., simple equal tooth
profiles or more complex multi-angled profiles. The particular profile
being dependent upon the required point of commit and rotation of the
locking collar 5. FIGS. 7 & 8 illustrate a hard stop feature 36 in path
16 that may prevent protrusion 11 from moving proximally after an
injection. This hard stopping of the locking collar 5 likewise prevents
guard 6 from substantial movement proximally, as defined earlier, from
its initial start position and, thus, positions the guard 6 in a "locked
out" safe position completely covering the distal end of needle 3.
Additionally, face 83 of protrusion 11 is biased against wall 85 of path
16, which may further prevent retraction of the guard 6 because the
collar 5 is prohibited from rotating.

[0067] A second possible embodiment 40 of the needle assembly is shown in
FIGS. 9-17. An exploded view of the components is shown in FIG. 9 and a
cross-sectional view of the fully assembled needle assembly 40 is
illustrated in FIG. 10. There is an upper body 41, a lower body 43, a
needle 42, a biasing member (spring 44), a locking collar 45, with
indicia 56 and 57 (see FIG. 14), a needle guard 46, and an outer sleeve
47 with one or more openings 63 (see FIG. 16) through which the indicia
are visible. As with the first embodiment described above, there are,
preferably, three indicator windows used to provide the user a clear
indication of the status of the needle assembly 40 when viewed from any
angle. For example, when the device has been used, a red color on the
locking collar 45 is visible because it has moved via rotation during use
and is now visible through the opening 63 in the outer sleeve 47.

[0069] Needle 42 is mounted to hub 48 (see FIG. 12) on the inside of upper
body 41. As illustrated, the guard 46 is not rotationally constrained,
but could be if necessary. As with the first embodiment, materials of
construction of the various components of our needle assemblies 1 and 40
are selected with the aim to achieve a low co-efficient of friction
between the components, especially between the locking collar 45 and the
needle guard 46, in order to minimize the risk that the guard 46 could be
used to backwind and unlock the system after use. For example, the
various components could be manufactured from polybutylene terephtalate
(PBT), Polyoxymethylene (POM, acetal homopolymer, polyacetal),
Polycarbonate (PC), and or combinations of these materials.

[0070] Generally, the operation of this embodiment is very similar to that
of the first embodiment described above, with the exception that the
locking collar 45 and the guard 46 do not have a crown of dog teeth.
Additionally, in this embodiment, as illustrated in FIG. 13, upper body
41 and lower body 43 are configured and arranged so that they nest
together with the lower body 43 surrounding the upper body 41 while
allowing a portion of the upper body's outer surface 60 to be in
alignment or flush with the outer surface 61 of the lower body 43. Upper
and lower bodies 41, 43 can be connected in any manner known to the art
such as snap fit, glued, welded, or the like. Upper and lower body 41, 43
may be fixed to each other such that a cavity may be formed inside the
body 41, 43. The cavity may be used to house a medicament container, e.g.
a hermetically sealed capsule. The two bodies 41, 43 may be arranged such
that each outer surface provides a portion of track 50 so that there will
be three paths, 51, 52, and 53. The inner surface of the locking collar
45 has an inner facing protrusion 55 (see FIG. 14) that travels in track
50 following the directional arrow 54 shown in FIG. 13 during use of the
needle assembly 40. This travel direction is virtually the same as
described for the first embodiment. Alternatively, the collar 56 provides
two or more protrusions 55 and the bodies 41, 43 provide two or more
tracks 50.

[0071] FIGS. 17 and 18 illustrate two-dimensionally the inner facing
protrusion 55 of the locking collar 45 (only one of the protrusions is
shown in the figures for clarity) with track 50, which comprises portions
of the outer surfaces of the upper and lower bodies 41, 43, during use of
the needle assembly 40. The figures illustrate the movement of the
inwardly facing protrusion 55 from the initial position (FIG. 17) to the
final locked position (FIG. 18) as the protrusions 55 on the locking
collar 45 follow paths 51, 52, and 53 of track 50. In this embodiment,
the collar 45 is passively rotated by the track 50 guiding the protrusion
55. FIG. 18 illustrates the hard stop feature 66 in path 53 that prevents
protrusion 55 from moving proximally once the guard 46 has extended to
its initial position after use. This hard stopping of the locking collar
45 may likewise prevent guard 46 from moving proximally from its initial
start position and, thus, positions the guard in a "locked out" safe
position completely covering the distal end of needle 42.

[0072] Exemplary embodiments of the present invention have been described.
Those skilled in the art will understand, however, that changes and
modifications may be made to these embodiments without departing from the
true scope and spirit of the present invention, which is defined by the
claims.

Patent applications by Naceur Rekaya, Leamington Spa GB

Patent applications by SANOFI-AVENTIS DEUTSCHLAND GMBH

Patent applications in class Having medical information (e.g., name of patient or medicament, etc.) means

Patent applications in all subclasses Having medical information (e.g., name of patient or medicament, etc.) means